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Pregnancy/Implantation Rates Using a Day 3 Score Versus Graduated Embryo Score Plus a Biochemical Marker (sHLA-G)

NCT ID: NCT00680238

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-06-30

Brief Summary

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Objective: To compare pregnancy rates and implantation rates when embryos are selected based on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.

Detailed Description

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Comparing pregnancy rates and implantation rates when embryos are selected using the most common criteria for embryo selection on day 3 - the morphology-(number of blastomere, their shape and size and the percentage of fragmentation)vs a graduated embryo score accumulated over 72 hours and the expression of sHLA-G at 44-46 hours post fertilization.

Conditions

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Infertility

Keywords

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Pregnancy implantation miscarriage sHLA-G

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Embryo selection for transfer based on a Day 3 score only.

Group Type NO_INTERVENTION

Human derived FSH

Intervention Type DRUG

Customized for each patient

B

Embryos for transfer by first selecting any embryos that had a positive sHLA-G expression of OD = 190 ±6 and correlating such with the highest GES score available.

Group Type ACTIVE_COMPARATOR

Human derived FSH

Intervention Type DRUG

Customized for each patient

Interventions

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Human derived FSH

Customized for each patient

Intervention Type DRUG

Other Intervention Names

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Bravelle

Eligibility Criteria

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Inclusion Criteria

* Self paying ART patients

Exclusion Criteria

* Abnormal uterus
* Specific Immunologic factors
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Stellenbosch

OTHER

Sponsor Role lead

Responsible Party

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Stellenbosch University

Principal Investigators

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Thinus Kruger, M.D. PhD.

Role: STUDY_DIRECTOR

University of Stellenbosch

Other Identifiers

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DKotze

Identifier Type: -

Identifier Source: org_study_id